Z-0118-2016Class II

CIOS ALPHA; image intensified fluoroscopic x-ray system

Name: Z-0118-2016 CIOS ALPHA; image intensified fluoroscopic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-08-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-08-17 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of CIOS ALPHA; image intensified fluoroscopic x-ray system on 2015-08-17. FDA classified it as Class II and gives the reason as "patient procedure interruption due to a potential system failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0118-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-17
Posted: 2015-10-23
Terminated: 2016-12-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: CIOS ALPHA; image intensified fluoroscopic x-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: patient procedure interruption due to a potential system failure
Root cause tag: design
FDA root cause: Device Design
Action: Customer Safety Advisory Notice XP038/15/S, dated August 17, 2015, was sent to direct accounts to alert them to the issue and provide work-around instructions to avoid potential risks.
Quantity in commerce: 44
Distribution: Nationwide Distribution.
Product codes and lots: model #10308191 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0118-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-23

Product code OWB

K132094Class IICios AlphaSiemens Medi Cal Solutions, Inc. / cleared 2014-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)